Used surgical instruments and related medical devices are typically handled by a Central Sterile Supply (hereafter “CSS”) department within a hospital or other related medical service facility, and is considered one of the most important service centers of a hospital. The CSS department typically processes used surgical instruments, and other types of re-usable medical devices, from a “dirty” or contaminated state and returns them to a sterile state. Turning to FIG. 4, a conventional CSS process is illustrated. Containers of instruments are received from a “dirty” side of CSS, where the instruments are unloaded, hand washed 401, and cleaned ultrasonically 402 and disinfected 403. Once cleaned, the instruments are counted 404, sorted 405, and packed 406 prior to placement in a steam sterilizer or autoclave 407. Once a container has been removed from the autoclave, it is then considered sterile and ready to be used.
An exemplary container described in connection with FIG. 4 is further illustrated in FIG. 3. Container 317 is typically made of metal, having the dimensions 18″(L)×12″(W)×6″(D), for holding dirty instruments arriving from an operating room (OR) or other clinical facility. While there are several sizes of containers, all are sized within certain limits to be able to fit into a standard washing and sterilizing machines. Container 317 has a cover that is latched in place at each end of the container by a secure and tamper proof mechanism. Containers 317 is further equipped with some sort of identifying label or tag 321 on an exterior surface. Tag 321 can be a printed label, barcode or a radio-frequency identification (RFID) tag. Tag 321 is used to associate the container with a particular count sheet listing its intended contents.
Container 317 also includes a tray 318, that fits inside container 317. Tray 318 is typically made of perforated steel or other suitable material, to allow fluids and other material to pass through during the various stages of the sterilization process. Tray 318 may be configured to accept dividers or inserts to organize or separate tools, and/or hold the tools in a particular fashion. Nevertheless, many trays in current use do not have inserts, but use stringers 320 as their prime organizational tool. As can be seen from the illustration in FIG. 3, stringer 320 is a U-shaped rod that is typically made of steel. The length of the “U” for stringer 320 runs through both finger loops of a suitable instrument, such as scissors or hemostats. Typically, stringer 320 is equipped with a means for closing off the top of the “U” to prevent the instruments from sliding off. When preparing instruments 319 for sterilizing, trays 318, inserts (not shown), stringers 320 and instruments 319 are placed inside of container 317 or alternately wrapped up in a special wrapping paper-like material.
As is known in the art, handheld surgical instruments 319 are typically made of stainless steel, though other materials may be equally suitable. Standard instruments include scissors, tweezer-like graspers, latching graspers (“hemostats”), and retractors of various shapes.
A large number of surgical instruments also contain a ratchet lock, typically with instruments having a finger ring configuration. Ratchets are located between each finger ring and the shank. The ratchets are smooth on one side and toothed on the other, and are often configured to have three “teeth”, where, when the instrument is closed, the toothed sides interlock. Thus, to close the instrument, the finger rings are drawn together and the jaws of the instrument meet before the teeth of the ratchet lock. Once the jaws meet, force must be applied to overcome the strength of the shafts and engage the teeth. Engagement of each successive tooth requires greater force. To open the instrument, first the ratchet must be disengaged. This is done by forcing the finger rings in the directions normal to their respective smooth sides of the ratchet. Once the teeth are separated, the finger rings should be moved apart to prevent reengagement of the teeth upon relaxation of the force.
Referring back to FIGS. 3 and 4, a conventional sterile supply process will be described in greater detail below. As an overview, the CSS process may be summarized chronologically as follows:                unload tray or container from the operating room (OR);        identify instruments;        open the instruments;        clean the instruments by hand;        process tray through ultrasonic cleaner;        flip the orientation of instruments as required;        arrange the instruments so they can be properly cleaned in the washer/disinfector;        process tray through washer/disinfector;        inspect for cleanliness;        inspect for mechanical integrity (i.e. no parts chipped, bent, missing or damaged);        inspect for functionality;        pull defective or unclean instruments;        lubricate appropriate equipment;        sharpen appropriate equipment;        demagnetize appropriate equipment;        replenish missing or defective instruments;        sort instruments and/or equipment;        count instruments and/or equipment;        pack appropriate instruments back onto stringers and/or tray;        document instruments and/or equipment on count sheet;        wrap the tray; and        update the hospital inventory system.        
After a surgical procedure, dirty instruments are sent to CSS with the intention of sterilizing and repackaging them for future use. Thus, the first step in the sterilization process is decontamination. Typically, a department worker opens a container and finds a tray with dirty, disorganized instruments. Each instrument is then manually washed or scrubbed (401). The purpose of this manual process is to physically remove deposits and to break up biofilms (such as dried blood) that may be adherent to the instruments.
At this point, the looped instruments are either thrown haphazardly back into the tray in an extreme open position, or they are placed on an extra wide stringer (320) that holds the instruments in the extreme open condition (i.e. as far as the instrument is physically capable of opening). The purpose of having them open is to expose the inner surfaces of the box lock hinge as much as possible, for cleaning and washing purposes. Other instruments such as retractors, which do not require opening, may also be thrown in at this point.
After the hand cleaning, the instruments proceed through a variety of rinsing and soaking procedures or baths. These baths may include ultrasonic cleaners or enzymatic solutions (402).
The instruments are then placed in a washer/disinfector (403), essentially a dishwasher for instruments where the instrument is cleaned by water impingement and detergent. These special-purpose dishwashers have a rotating spray bar which emits high pressure water and detergent spray to clean the instruments by impingement of the water jets on the instrument surfaces. It is optimal to have the looped instruments held in a wide open stance for this step to expose the critical locations on the instrument which may otherwise be obscured from the water jets.
When the instruments leave the washer/disinfector, they are considered decontaminated. Further processing continues on what is called the “clean” side of CSS (see FIG. 4). Here the instruments are inspected, counted 404, sorted 405, and repacked 406 into their containers. At this point, instruments are inspected for damage and to ensure that they are functioning properly. Thus, for example, a looped instrument's hinging mechanism must move freely, and cutting tools must be sufficiently sharp. Any broken or damaged instruments should be pulled from the set and either discarded or sent for maintenance. Some instruments also require routine maintenance such as lubrication, sharpening, or demagnetizing. These simple maintenance functions may be performed by CSS personnel at this time.
During the count and sort process (404, 405), the instruments in the container are compared to its count sheet. A count sheet specifies the type and quantity of each instrument to be included in the container. The count generated in CSS will form the basis for the count in the operating room (OR). During a procedure the surgical staff must maintain an accurate count of all the instruments to ensure none are inadvertently left behind in the patient. A mistake in the original count from CSS can significantly complicate the count in the OR. For example, an undercount in CSS can contribute to an instrument being erroneously left in the body cavity. On the other hand, an over-count can contribute to a false alarm, giving the erroneous appearance that an instrument is missing. Accordingly, the surgical team must search for the nonexistent instrument, prolonging the procedure and the time the patient is under anesthesia.
Many CSS facilities still rely on paper for their count sheets. CSS facilities that are beginning to incorporate automated systems utilize software and/or instrument barcodes to help automate the process. Nevertheless, in either case, conventional CSS processes are still time consuming and error prone tasks.
As part of the sorting process, looped instruments are manually placed on a standard width stringer, so that similar instruments are adjacent to one another and preferably arranged largest to smallest in size. The standard width stringer holds the instruments in a nearly closed but un-ratcheted position, which is referred to in the art as a “soft” close. The non-looped instruments, such as retractors, are arranged on the bottom of the tray. The stringer full of instruments is placed into the tray, and the tray is placed into a container. The CSS worker will typically sign the count sheet and place it into the container with the tray. The container is then latched and ready for the sterilization process as mentioned above.
For CSS systems utilizing automated processes, a robotic automation mechanism is programmed and configured to manipulate relevant objects. Examples of such robotic systems may be found in U.S. Pat. No. 7,164,968, titled “Robotic Scrub Nurse,” issued Jan. 16, 2007, which is incorporated by reference in its entirety herein. Under such systems, robotic manipulations for a given process must handle objects in a prescribed manner, and often run into situations where the manner of manipulation is beyond the means of the robot. In such cases, additional devices are required in order to achieve these goals. A device designed for such a purpose is said to be robot-ready. Additionally, there are increasing varieties of surgical instruments having different sizes, shapes, and characteristic features. Certain instruments may be found in different states (e.g., open, closed, upside-down) over the course of the sterile supply process. Accordingly, it is desirable to have a system and method for handling various types of instruments regardless of state, and to be able to transfer the instruments between states.